Device and method for improving function of heart valve

• US 9,056,009 B2
• Filed: 06/15/2012
• Issued: 06/16/2015
• Est. Priority Date: 11/13/2006
• Status: Active Grant

• Current Assignee: Medtentia International Ltd. Oy
• Original Assignee: Medtentia International Ltd. Oy
• Inventors: Kernen, Olli
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US13/525,093
• Publication Number:
  US 20120316640A1
• Time in Patent Office: 1,096 Days
• Field of Search: 623/2.36, 623/1.24, 623/2.1, 623/2.17, 623/2.37
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/006 modular

Abstract

A device for improving the function of a heart valve comprises a first loop-shaped support, which is configured to abut a first side of the heart valve, and a first flange unit being connected to said first loop-shaped support. The flange unit is configured to be arranged against said annulus when said first loop-shaped support is abutting said heart valve.

Claims

1. A method for repairing a heart valve, said heart valve being comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, said method comprising:

delivering a medical device comprising a first loop-shaped support and a first flange unit extending radially from the said first loop-shaped support to the heart valve,

positioning said first loop-shaped support such that it abuts a first side of the heart valve,

positioning said first flange unit such that it abuts said annulus,

sealing said first flange unit against said annulus with a sealing surface of said first flange unit,

fixating said device by attaching said first flange unit to said annulus

wherein;

said first flange unit extends radially downward at an angle α

of between 30° and

60°

to a diametric plane of said first loop-shaped support before said positioning to abut the first side of the heart valve and

positioning said first flange unit such that it abuts said annulus comprises conforming said first flange unit to said annulus and thereby changing the shape of said first flange unit to extend upwardly from said annulus.

2. The method according to claim 1, wherein said first flange unit extends radially inwards and said method comprises supporting said leaflets with said flange unit.

3. The method according to claim 1, wherein an outer periphery of said first flange unit comprises a reinforcing element and said method comprises conforming the flange unit to the annulus before fixating said device by placing staples and/or sutures in an area of said flange comprising said reinforcing element.

4. The method according to claim 1, wherein said delivering of the device to the heart valve is performed using a catheter.

5. The method according to claim 1, wherein said first side of the heart valve is the atrial side.

6. The method according to claim 4, wherein said first loop-shaped support is made of a memory shape material and said method further comprises compressing said device into a delivery shape before delivery to the heart valve and changing the device to a delivered shape after delivery.

7. The method according to claim 1, wherein said medical device further comprises a second loop-shaped support and the method further comprises:

positioning said second loop-shaped support such that it abuts a second side of the heart valve opposite to said first side and

trapping a portion of the valve tissue between the first and second loop-shaped supports.

8. A method for replacing a heart valve, said method comprising:

delivering a medical device to the heart valve, said device comprising an artificial valve, a first loop-shaped support and a flange unit extending radially from the loop-shaped support,

positioning the loop-shaped support such that the medical device abuts only a ventricular side or an atrial side of the heart valve,

positioning the flange unit such that it abuts the annulus,

sealing said flange unit against said annulus with a sealing surface of said flange unit, and

fixating the device by attaching the flange unit to the annulus

wherein;

said flange unit extends radially downward at an angle α

of between 30° and

60°

to a diametric plane of said first loop-shaped support before said positioning to abut the first side of the heart valve and

positioning said flange unit such that it abuts said annulus comprises conforming said first flange unit to said annulus and thereby changing the shape of said first flange unit to extend upwardly from said annulus.

10. The method according to claim 8, and further comprising attaching the artificial valve to the medical device before delivering the medical device to the heart valve.

9. A method of treating a heart valve problem comprising:

providing an implant having a coil-shaped support frame and a flange extending radially from at least a first portion of said coil-shaped support frame;

abutting said first portion of said coil-shaped support frame against a first side of said heart valve;

positioning said flange against a first side of an annulus of said heart valve;

sealing said flange against said annulus;

abutting a second portion of said coil-shaped support frame against a second side of said heart valve, opposite said first side, and thereby trapping valve tissue between said first and second portions of said coil-shaped support frame; and

attaching said flange to said annulus;

wherein said flange extends radially from at least a portion of said second portion of said coil-shaped support frame and said method further comprises;

positioning said flange against said second side of said annulus;

sealing the flange against said annulus on said second side of said heart valve; and

attaching the flange to said annulus on said second side of said heart valve.

11. The method according to claim 9, wherein an outer periphery of said flange comprises a reinforcing element and said attaching said flange to said annulus comprises placing staples and/or sutures in an area of said flange comprising said reinforcing element.

12. The method according to claim 9, wherein said flange extends radially outward from said first portion of said coil-shaped support frame.

13. The method according to claim 9, wherein said flange extends radially inward from said first portion of said coil-shaped support frame.

14. The method according to claim 9, and further comprises inserting one of said first and second portions of the coil-shaped support through a commissure to extend along one side of the valve.

15. The method according to claim 9, wherein said trapping valve tissue keeps the device in a correct position during said fixating of said device.